Label: COPPERGEL- camphor, menthol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 4, 2018

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS:

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:

    Camphor 3.5%

    Menthol 3.5%

  • PURPOSE

    Purpose:

    Topical Analgesic

  • INDICATIONS & USAGE

    USES: for the temporary relief of minor aches and pains in muscles and joints associated with:

    • strains
    • sprains
    • sports injuries
    • arthritis
    • bruises
  • WARNINGS

    WARNINGS:

    For external use only.

  • DO NOT USE

    Do not use

    • with other topical pain relievers
    • with heating pads or heating devices
  • WHEN USING

    When using this product

    • do not get into eyes
    • do not apply to wounds or damaged skin
    • do not bandage tightly
  • STOP USE

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days
    • redness or irritation develops
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS:

    • clean the affected area before applying product
    • adults and children 2 years of age and older: apply to affected not more than 3 to 4 times daily
  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Blue 1, Copper PCA, Ethylhexylglycerin, Eucalyptus Globulus (Eucalyptus) Leaf Oil, Isopropyl Alcohol, Phenoxyethanol, Triethanolamine, Water (Aqua)

  • SPL UNCLASSIFIED SECTION

    Distributed By: Copper Relief, LLC

    Wayzata, MN 55391

    www.coppergel.com

    MADE IN THE USA

  • PRINCIPAL DISPLAY PANEL

    CopperGel

    KNOCK OUT THE PAIN™
    Topical Analgesic Gel

    NET WT. 3 OZ (85g)

    coppergel label

  • INGREDIENTS AND APPEARANCE
    COPPERGEL 
    camphor, menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72081-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.5 g  in 100 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    COPPER PIDOLATE (UNII: 497G7G1SL1)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72081-001-031 in 1 CARTON02/05/2018
    185 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/05/2018
    Labeler - CopperRelief, LLC (080979585)
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